Ostomy system with repositionable pouch

ABSTRACT

The ostomy system with mounting wafer and repositionable pouch includes a resealable tape provided on one of the system members and a releasable film provided on the other system member. In a preferred embodiment of the invention the resealable tape is located on a faceplate of the pouch and the releasable film is located on the body-side mounting wafer. The pouch is thus secured to the body-side mounting wafer by engaging the resealable tape with the releasable film. The resealable tape and the releasable film coupling arrangement permit repeated removal of the pouch from the body-side mounting wafer and repeated resecurement of the pouch to the mounting wafer. The pouch can thus be repositioned relative to the mounting wafer even after the pouch has been worn for a day.

This is a continuation application of Ser. No. 10/464,579, filed on Jun.17, 2003, which is a continuation of Ser. No. 08/390,180, filed Feb. 17,1995.

BACKGROUND OF THE INVENTION

This invention is directed to ostomy systems, and more particularly to anovel ostomy system that permits repeated removal of an adhesivelyinstalled ostomy pouch to permit repositioning of the pouch around thestoma.

Ostomy systems with adhesive coupling devices for securing an ostomypouch around a stoma are shown in European Patent ApplicationPublication 0 611 122 A1. After an ostomy pouch has been adhesivelysecured around a stoma, it is often desirable to make a furtherreadjustment of the pouch position. However, it is well known thatremoval of an adhesively secured pouch from its position around a stomacan cause wrinkling or kinks in the faceplate of the pouch that includesthe adhesive coupling member. Pouch removal can also cause wrinkling andkinks in a body-side mounting wafer that surrounds the stoma and forms alanding surface for the pouch faceplate when the pouch is adhesivelysecured to the abdominal area.

Removal and resecurement of an adhesively mounted closed-end pouch afterthe pouch has been worn for at least a day is especially troublesomesince the mounting wafer landing surface for the pouch does not usuallyremain flat and smooth after a full day's wear. Readherence of the pouchto a non-smooth landing surface is likely to produce gaps or channels atthe adhesive interface between the pouch faceplate and the body-sidemounting wafer. Such gaps are detrimental to the integrity of the sealbetween the pouch and wafer, and can provide a path for undesirableleakage of vapor and material from the pouch.

Thus, an ostomy system which has leaks at the interface between thepouch and the body-side wafer due to repositioning of the pouch mayrequire complete replacement of the entire system before it has beenused for the normal time duration.

It is also common practice for a user to have assistance in placing orpositioning a pouch on the abdomen in order to ensure that the pouch issatisfactorily positioned around the stoma. However, if assistance isnot available when needed, the user may proceed to install the ostomypouch without assistance, thereby risking unsatisfactory positioning anda need for readjustment of the pouch position.

The risk of wrinkle formation at the interface between an adhesivelysecured pouch and a body-side wafer because of a prospective need forrepositioning of the pouch can discourage use of adhesively securedpouches, even though adhesive coupling is generally less bulky thanmechanical coupling devices.

It is thus desirable to provide an ostomy system that permits easyremoval and repositioning of an adhesively secured pouch withoutdamaging the pouch faceplate or the mounting wafer and withoutcompromising the leak-tight securement of the pouch during suchrepositioning.

OBJECTS AND SUMMARY OF THE INVENTION

Among the several objects of the invention may be noted the provision ofa novel ostomy system, a novel ostomy system with a repositionableostomy pouch, a novel ostomy system wherein the pouch is adhesivelysecured and repositionable without compromising a leak-tight sealbetween the pouch and a body-side wafer, a novel ostomy system whereinan installed body-side wafer remains substantially flat and smooth toprovide a flat landing zone around the stoma, even after the pouch isremoved from the installed wafer, a novel ostomy system wherein astiffening member is provided on a body-side wafer to minimize theformation of wrinkles or folds on an installed wafer duringrepositioning of a previously installed ostomy pouch, a novel ostomysystem wherein an ostomy pouch includes a refastenable adhesive member,and a novel method of repositioning an ostomy pouch around a stomalopening.

Other objects and features of the invention will be in part apparent andin part pointed out hereinafter.

In accordance with the invention, the ostomy system includes arepositionable pouch, which can be closed-end or drainable, and abody-side mounting wafer. The pouch comprises an envelope formed offlexible plastic sheet material that defines a chamber for collection ofbody waste from the stoma. A waste inlet opening is formed in the pouchto receive waste material that passes from the stoma into the collectionchamber. Coupling means for securing the pouch to the body-side mountingwafer are provided on the pouch envelope at the waste inlet opening. Thebody-side mounting wafer has a stomal opening and an adhesive layer onone side for securement of the wafer to the body surface around thestoma. An opposite side of the wafer is engageable with the pouchcoupling means.

The ostomy system coupling means include a resealable tape and areleasable film, one of which is provided on the pouch and the other ofwhich is provided on the body-side mounting wafer.

In a preferred embodiment of the invention, the resealable tape isprovided on the pouch and the releasable film is provided on thebody-side mounting wafer. Thus the pouch can be secured to the waferwhen the resealable tape engages the releasable film. The releasablefilm and the resealable tape permit repeated removal of the pouch fromthe wafer and repeated resecurement and/or replacement of a closed-endpouch to the wafer.

Under this arrangement the pouch can be easily repositioned on thebody-side wafer, even after the pouch has been worn for a day.

The ostomy system also includes a support means disposed behind thereleasable film to inhibit the formation of wrinkles on the releasablefilm and help keep the film flat and smooth. By maintaining thereleasable film flat and smooth, leak-tight seals are obtainable betweenthe pouch and the wafer, even when the pouch is repositioned severaltimes on the body-side wafer.

A stiffening member can also be provided behind the resealable tape ofthe pouch coupling member to facilitate application of the pouch to thebody-side wafer.

In several embodiments of the invention the resealable tape of the pouchis mounted on an outside surface of the pouch envelope. In otherembodiments of the invention the resealable tape is mounted on an insidesurface of the pouch envelope, such that exposed portions of theresealable tape are bordered by the pouch side-wall.

In some embodiments of the invention the support means of the body-sidewafer are coextensive with the releasable film and a body-side adhesive.In other embodiments of the invention the support means include twosupport members, one of which is of smaller extent than the releasablefilm.

The faceplate of the pouch, which includes the pouch coupling member,can be heat-welded or adhesively bonded to a wall of the pouch.

The invention also includes a method of repositioning an ostomy poucharound a stomal opening, including the securing of a body-side waferaround the stomal opening, providing the mounting wafer with a landingsurface formed of releasable film and providing the ostomy pouch with anadhesive coupling having an exposed resealable tape for engagement withthe releasable film of the body-side mounting wafer to permit repeatedremoval, replacement and resecurement of the pouch to the mountingwafer.

The invention accordingly comprises the constructions and methodhereinafter described, the scope of the invention being indicated in theclaims.

DESCRIPTION OF THE DRAWINGS

In the accompanying drawings, FIG. 1 is a plan view of an ostomy systemincluding an ostomy pouch and a body-side wafer that incorporate oneembodiment of the invention;

FIG. 2 is a sectional view thereof, taken on the line 2-2 of Fig. i;

FIG. 3 is a sectional view similar to FIG. 2, showing the ostomy systemon an abdominal wall in alignment with a stoma;

FIG. 4 is a view similar to FIG. 3, showing the ostomy pouch detachedfrom the body-side wafer prior to repositioning of the pouch against thewafer;

FIG. 5 is a fragmentary sectional view thereof;

FIG. 6 is a fragmentary sectional view of another embodiment of theinvention;

FIG. 7 is a fragmentary sectional view of further embodiment of theinvention;

FIG. 8 is a fragmentary sectional view of an additional embodiment ofthe invention;

FIG. 9 is a fragmentary sectional view of a further additionalembodiment of the invention;

FIG. 10 is a plan view of an ostomy system including an ostomy pouch anda body-side wafer that incorporate a further embodiment of theinvention;

FIG. 11 is a sectional view thereof, taken on the line ii-ii of Fig. i0;

FIG. 12 is a view similar to Fig. ii, showing the i0 ostomy system on anabdominal wall in alignment with a stoma; and

FIG. 13 is a view similar to FIG. 12, showing the ostomy pouch detachedfrom the body-side wafer prior to repositioning of the pouch against thewafer.

Corresponding reference characters indicate corresponding partsthroughout the several views of the drawings.

DETAILED DESCRIPTION OF THE INVENTION

An ostomy system incorporating one embodiment of the invention isgenerally indicated by the reference number 10 in FIG. 1.

The ostomy system 10 includes a pouch 12 and a body-side mounting wafer14, shown in separated position in FIG. 4. The pouch 12, which isexpandable, is formed of an envelope of suitable flexible thermoplasticmaterial known in the art of pouch construction, such material beingimpermeable to gas and water.

The pouch 12 includes a front wall 20 that faces away from an abdominalsurface 22 (FIG. 8), and a rear wall 24 that confronts the abdomen 22.The front and rear walls 20 and 24 of the pouch 12 are joined togetherby a peripheral thermoweld 26. The pouch 12 further includes a topportion 30 with rounded corners and opposite side portions 32 and 34that diverge slightly from the top portion 30 to a bottom portion 36.The pouch envelope thus defines a waste collection chamber 38.

A waste inlet opening 40 having a diameter of approximately two inchesis formed in the rear wall 24 nearer the top portion 30 than the bottomportion 36. The waste inlet opening 40 communicates with the collectionchamber 38 and is bordered by a washer-shaped adhesive faceplate 42attached to the rear wall 24 by an annular thermoweld 44. The faceplate42 is preferably formed of a resealable tape 46 which can be a two-sidedadhesive tape of the type used in the refastenable tape closure system9920 and/or 9835 manufactured by the 3M Company of Minneapolis, Minn.The resealable tape 46 includes a hypo-allergenic acrylicpressure-sensitive adhesive on ethylene vinyl acetate or polyethylenetape with silicone release paper. The faceplate 42 has an inner diameterof approximately two inches and an outer diameter of approximately threeand one-half inches.

A stiffening member 48 (FIG. 1), preferably formed of elastomericmaterial, can be laminated to the back of the resealable tape 46 beforethe faceplate 42 is adhered to the pouch. The stiffening member 48reduces flexibility of the faceplate 42 and facilitates application andremoval of the pouch 12 from the mounting wafer 14. Preferably thestiffening member 48 is a plasticized flexible polyvinyl chloride sheetmaterial 0.010″-0.080″ thick. For purposes of simplicity, the faceplate42, as shown in Figures other than FIG. 1, will be understood toincorporate the stiffening member 48.

If desired, the faceplate 42 can be adhered rather than heat welded tothe pouch wall 24, as by applying pressure-sensitive adhesive to thenon-coated side to permit an adhesive bond between the faceplate 42 andthe rear wall 24. Although not shown, a silicone release paper coversthe exposed surface of the faceplate 42 to protect the adhesive surfaceof the tape 46 prior to use of the pouch 12.

The body-side mounting wafer 14 is generally square with rounded cornersand has a central opening 60 with a diameter of approximately one-halfto one-and-three-quarter inches. The wafer 14 is sized to extend beyondthe periphery of the faceplate 42 and includes a first layer 50.Preferably the layer 50 is formed of a hydrocolloid adhesive,approximately 0.030 to 0.080 inches thick, such as the type sold underthe trademark Stomahesive® or Durahesive® by Bristol-Myers SquibbCompany of New York, N.Y. A support layer 52, of substantially identicalsize as the layer 50, is laminated to the layer 50 and facilitatesapplication of the pouch 12 to the wafer 14. The support layer 52 isformed of a plasticized, flexible polyvinyl chloride sheet materialapproximately 0.010 to 0.080 inches thick.

A release film 54, approximately 0.003 inches thick, also substantiallyidentical in size to the layer 50, is laminated to the support layer 52to function as a target or landing area for the refastenable faceplate42 of the pouch 12. Preferably the release film 54 is a single-coated,pressure-sensitive adhesive medical tape of the type sold by the 3MCompany of St. Paul, Minn., under the designation of 3M Release Tape9921, or Tegaderm, which has a controlled release surface treatment. Therelease film 54 engages the adhesive faceplate 42 of the pouch 12 forattachment of the pouch 12 to the wafer 14.

The release film 54 permits removal of the pouch faceplate 42 from thebody-side wafer 14 after prior pouch attachment such that the pouch 12can be repositioned on the wafer 14. Removal and reattachment orreplacement of the pouch 12 can be accomplished numerous times. Sincecontours can exist around the stomal area, the landing zone on the 25release film 54 may not remain flat and smooth, especially after thebody-side wafer 14 is worn for more than a day. The support layer 52inhibits the formation of wrinkles on the release film 54, helping tokeep the film 54 flat and smooth. It has been found that a leak-tightseal is obtainable even after numerous repositionings or replacements ofthe pouch 12 on the wafer 14.

A known silicone release paper 56 (FIG. 2) is provided on the outside ofthe adhesive layer 50 to protect the layer 50 until the body-sidemounting wafer 14 is ready for installation on the abdominal surface 22.In using the ostomy system 10, the release paper 56 is removed from thebody-side mounting wafer 14. The wafer 14 is secured to the abdominalwall at the layer 50 such that an opening 60 in the mounting wafer 14aligns-with a stoma 62. Any protective covering (not shown) provided onthe release film 54 is also removed to expose the landing surface of therelease film 54.

The silicone release paper 56 is removed from the resealable adhesive 46of the faceplate 42. The pouch 12 is installed on the abdomen by joiningthe adhesive surface 46 of the faceplate 42 to the release film 54 suchthat the pouch opening 40 is substantially coaxial with the waferopening 60 in the manner shown in FIG. 8.

In some instances the desired coaxial relationship between the pouchopening 40 and the wafer opening 60 is not obtained, or the pouchopening 40 is not comfortably positioned around the stoma 62. Thus itbecomes necessary to reposition the pouch 12 relative to the mountingwafer 14.

The release film 54 of the wafer 14 permits easy removal of the adhesivelayer 46 of the pouch faceplate 42 from the wafer 14 to separate thepouch 12 from the wafer 14 in the manner shown in FIG. 4. The pouch 12can then be repositioned relative to the wafer 14.

The stiffening layer 48 and the support layer 52 help providesubstantially smooth wrinkle-free surfaces on the wafer 14, and thepouch faceplate 42 when the pouch 12 is resecured to the wafer 14 duringrepositioning of the pouch 12.

Once the pouch 12 is resecured to the wafer 14 in a manner similar tothat previously described, further adjustment, if desired, can still bemade. Thus it is possible to remove and reposition or replace the pouchseveral times when needed.

Another embodiment of the ostomy system is generally indicated by thereference number 70 in FIG. 6. The ostomy system 70 includes a body-sidewafer 74 that differs from the wafer 14 of the system 10 by replacementof the support layer 52 of the system 10 with a support layer 76. Thesupport layer 76 is preferably formed of polyethylene closed-cell foamwith pressure-sensitive adhesive that is approximately 0.015 to 0.050inches thick, to laminate to the hydrocolloid adhesive layer 50. Thesystem 70 is otherwise similar to the system 10 and is used in a manneras previously described for the system 10.

An ostomy system incorporating a further embodiment of the invention isgenerally indicated by the reference number 80 in FIG. 7. The ostomysystem 80 includes a body-side wafer 84 that differs from the wafer 74of the ostomy system 70 by replacement of the body-side adhesive layer50 with a body-side adhesive layer 86. The layer 86 is formed of thesame material as the layer 52 but is of a smaller width than the layer52 by, for example, approximately one-half inch on each side. The system80 is otherwise similar to the system 10 and is used in a manner similarto that previously described for the system 10.

A further embodiment of the ostomy system is generally indicated by thereference number 90 in FIG. 8. The ostomy system 90 includes a body-sidewafer 94 that differs from the wafer 84 of the system 80 by inclusion ofan additional support layer 96 provided between the layers 76 and 86.The support layer 76 is formed of elastomeric material, such aspolyvinyl chloride, that is approximately 0.010 to 0.080 inches thick,and has substantially the same outer dimensions as the layer 86. Thesystem 90 is otherwise similar to the system 10 and is used in a mannersimilar to that previously described for the system 10.

An ostomy system incorporating another embodiment of the invention isgenerally indicated by the reference number 100 in FIG. 9. The ostomysystem 100 includes a body-side wafer 104 that differs from the wafer 94by replacement of the support layer 96 in the system 90 with a supportlayer 106. The support layer 106, which is approximately 0.010 to 0.050inches thick, is preferably formed of Silipos material, manufactured bySilipos Inc. of New York, N.Y. The layer 106 has substantially the sameoutside dimensions as the layer 86. The system 100 is otherwise similarto the system 10 and is used in a manner similar to that previouslydescribed for the system 10.

An ostomy system incorporating still another embodiment of the inventionis generally indicated by the reference number 110 in FIG. 11.

The ostomy system 110 includes a pouch 112 and a body-side mountingwafer 14, shown in separated position in FIG. 13.

The pouch 112 includes a faceplate 114 similar to the faceplate 42 ofthe system 10. However, the faceplate 114 is adhered to an inner surface23 of the rear wall 24 by an annular thermoweld 116 or apressure-sensitive adhesive. Thus a portion of the faceplate 114projects into the pouch opening 40, as most clearly shown in FIG. 13.The surface of the faceplate 114 is constituted of the resealable tape46, which is engageable with the layer 54 of the wafer 14.

As noted with the system 10, the faceplate 114 can be adhered ratherthan heat-welded to the pouch wall.

In using the ostomy system 1 i0, the wafer 14 is secured to theabdominal wall 22 in a manner previously described for the system 10.The pouch 112 is prepared for engagement with the body-side mountingwafer 14 by removing a silicone release paper (not shown) applied overthe resealable tape 46 to protect the surface of the tape untilengagement is to be accomplished.

The pouch 112 is installed on the abdomen by joining the adhesivesurface 46 of the faceplate 114 to the release film 54 of the wafer 14in the manner shown in FIG. 12.

If desired, the pouch 112 can be repositioned relative to the wafer 14in a manner similar to that previously described for the system 10.

In other embodiments of the ostomy system that incorporate the presentinvention, the body-side mounting wafer 14 of the system ii0 can bereplaced by the mounting wafers 74, 84, 94 or 104. Thus the pouch 112can be combined with any of the five mounting wafer arrangementspreviously described to achieve the objectives of the invention.

Some advantages of the present invention evident from the foregoingdescription include an ostomy system that permits easy removal of apouch from a body-side mounting wafer without the need for mechanicalcoupling arrangements or bulky latching devices. The resealable adhesivesecurement of the pouch to the body-side mounting wafer also permitseasy repositioning of the pouch around the stoma to provide the userwith an option for adjusting the position of the pouch around the stoma.Such adjustment or repositioning and replacement of the pouch isobtainable without compromising the integrity of the seal between thepouch and the body-side wafer despite repeated removal and repositioningof the pouch. Thus an adhesively secured pouch that is removed becauseof a positioning problem need not be discarded, but can be reinstalledand used until the pouch is ready for disposal. The repositioningcapability of the present invention eliminates a common source offrustration to the user of adhesively secured ostomy pouches.

In view of the above, it will be seen that the several objects of theinvention are achieved and other advantageous results attained.

As various changes can be made in the above constructions and methodwithout departing from the scope of the invention, it is intended thatall matter contained in the above description or shown in theaccompanying drawings shall be interpreted as illustrative and not in alimiting sense.

1-29. (canceled)
 30. An ostomy system comprising a. an ostomy pouchincluding a pouch envelope formed of flexible plastic material defininga waste collection chamber for body waste that passes through a stoma, awaste inlet opening formed in said envelope for passage of wastematerial from said stoma to said collection chamber, a flexible annularadhesive pouch coupling member on said envelope at said waste inletopening, said pouch coupling member having a resealable tape; b. abody-side mounting wafer having a stomal opening, said mounting waferbeing engageable with the coupling member of said pouch, said mountingwafer having one side with an adhesive layer for securement to a bodysurface around a stoma, and an opposite side with a releasable filmpermanently secured to said wafer for engagement with the resealabletape of said pouch coupling member, such that said pouch can be securedto said wafer when the resealable tape of the pouch coupling memberengages the releasable film of the wafer, said releasable film extendingfrom an inner periphery surrounding said stomal opening to an outerperiphery, said releasable film and said resealable tape permittingrepeated removal of said pouch from said wafer and repeated resecurementand replacement of said pouch to said wafer; c. support meanscoextensive and underlying said releasable film for preventing wrinklingof any part of said releasable film; and d. a stiffening layer memberunderlying said resealable tape for reducing the flexibility of saidpouch coupling member and facilitating application and removal of saidresealable tape of said pouch coupling member to said releasable filmand a substantially smooth wrinkle-free surface on said body sidemounting wafer.
 31. The ostomy system as claimed in claim 30, whereinsaid resealable tape has a front and back surface, said front surfaceengaging said releasable film, and said back surface having saidstiffening layer laminated thereto.
 32. The ostomy system as claimed inclaim 30, wherein said stiffening layer is formed of elastomericmaterial.
 33. The ostomy system as claimed in claim 32, wherein saidelastomeric material is a sheet of flexible polyvinyl chloride.
 34. Theostomy system as claimed in claim 33, wherein said sheet of flexiblepolyvinyl chloride is 0.010-0.080 inches thick.